Animal Welfare Assurance

ANIMAL WELFARE ASSURANCE

in accordance with the PHS Policy for

Humane Care and Use of Laboratory Animals

I, Dr. John Morello, Associate Provost, as named Institutional Official for animal care and use at University of Mary Washington, hereinafter referred to as Institution, by means of this document, provide assurance that this Institution will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.

Most recent annual report of UMW Institutional Animal Care and Use Committee

I. APPLICABILITY OF ASSURANCE

This Assurance is applicable to all research, research training, experimentation,

biological testing, and related activities, hereinafter referred to as activities, involving live vertebrate animals supported by the Public Health Service (PHS) and conducted at this Institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS‑conducted or -supported activity by this Institution.

“Institution” includes the following branches and major components of University of Mary Washington: The College of Arts and Sciences

Jepson Science Center 486.75 nasf

Annex A Facility 110 nasf

“Institution” also includes the following: Stafford and Dahlgren Campuses of the University of Mary Washington.

[NOTE: Only those entities listed in this section will be entitled to use the Assurance number for grant and contract submissions to PHS agencies.]

II. INSTITUTIONAL COMMITMENT

A. This Institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.

B. This Institution is guided by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.”

C. This Institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility, this Institution will ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance, as well as all other applicable laws and regulations pertaining to animal care and use.

D. This Institution has established and will maintain a program for activities involving animals in accordance with the “Guide for the Care and Use of Laboratory Animals” (“Guide”).

III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE

A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are as follows:

The IACUC will report directly to the Institutional Official (Provost), who in turn will report to the President, University of Mary Washington. The Veterinarian also has the ability to report directly to the Institutional Official, outside of the IACUC reporting.

B. The qualifications, authority, and percent of time contributed by the veterinarian who will participate in the program is as follows:

Name: Dr. G. Frank Wagner

Qualifications:

Degrees: BS Biology (VTech), DVM (Univ. Georgia)

Training and/or experience in laboratory animal medicine or experience with the care animals covered by this assurance (mice and rats): Dr. Wagner was born and raised in Northern Virginia. He attended Virginia Tech, and finished his degree at the University of Georgia in 1971. After graduation Dr. Wagner returned to Northern Virginia to work as an associate veterinarian before purchasing the Fredericksburg Animal Hospital in 1974. At that time he was one of five veterinarians in the area. (39 years as a practicing veterinarian)

Dr. Wagner has a special interest in surgery. His studies include orthopedic surgery at Ohio State University and an advanced orthopedics course in Switzerland.

Authority: Dr. Wagner has delegated program authority for the Institution’s animal care and use program.

Time Contributed to Program: Dr. Wagner will be available for IACUC program duties approximately 8 hours per academic semester.

C. The Institutional Animal Care and Use Committee (IACUC) at this Institution is properly appointed in accordance with the PHS Policy IV.A.3.a and is qualified through the experience and expertise of its members to oversee the Institution’s animal care and use program and facilities. The IACUC consists of at least five members, and its membership meets the composition requirements set forth in the PHS Policy, Section IV.A.3.b. Attached is a list of the chairperson and members of the IACUC and their names, degrees, profession, titles or specialties, and institutional affiliations.

1. Review at least once every six months (semi-annually) the institution’s program for humane care and use of animals, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program evaluations are:

a. The semiannual program review is conducted at a convened meeting (regular or special).

b. Each member receives or has received a copy of the Guide, the previous semiannual program and facilities inspection report, IACUC’s policies and procedures manual (containing their charges and responsibilities), and UMW’s Institutional Animal Care and Use Program Evaluation checklist [modeled after that suggested by the Office of Laboratory Animal Welfare (OLAW)] which reviews all aspects of the animal use program including administration.

c. In addition, agenda items for scheduled monthly IACUC meetings include review, discussion, and/or recommend revisions to improve the level of care and to insure compliance.

d. As some members of the IACUC are active utilizers of laboratory animals, they are constantly reviewing the program relevant to their work.

2. Inspect at least once every six months (semi-annually) all of the institution’s animal facilities, using the Guide as a basis for evaluation. The IACUC procedures for conducting semiannual program evaluations are:

a. At scheduled intervals, at least once every six months, each facility or area will be completely inspected by no less than two (2) IACUC members and the results discussed at a convened meeting (regular or special).

b. Included in the facilities inspections are inspections of animal care records, IACUC administrative records, staff interviews, and random interviews with investigators holding active animal use protocols and other laboratory staff involved with animal care and utilization.

c. Any item not in compliance with the Guide will be recorded and submitted to the Institutional Official along with recommended corrective actions; major deficiencies will also be reported to OLAW.

d. The date(s) of each inspection will be included with the annual Assurance Document update. UMW’s semiannual facilities inspection is normally conducted in conjunction with their semiannual program evaluation.

3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the Institutional Official (Provost), University of Mary Washington. The IACUC process for developing reports and submitting them to the Institutional Official are:

a. The Chair prepares a draft report based, in part, upon the facilities inspection subcommittee reports and applicable program review results.

b. At a convened meeting, the draft report along with any additional facilities inspection or program review information is discussed and compiled into a final report.

c. Deficiencies identified during the facilities and program reviews are detailed in the report with recommended corrective actions and deadlines for correction listed. Deficiencies are classified as either major, usually those directly affecting animal health, or minor in the semiannual report by the IACUC during the convened meeting.

d. This report, along with any minority opinions and/or recommendations, are endorsed by the Committee and forwarded to the Institutional Official.

4. Review concerns involving the care and use of animals at the Institution. The IACUC procedures for reviewing concerns are as follows:

a. Concern(s) involving the care and use of animals may be submitted to the current Chair, IACUC, the Dean of The College of Arts and Sciences, the Veterinarian, the Executive Vice Provost, or the Provost.

b. All such concerns will be presented to the IACUC for review, discussion, and suggested resolution, all of which will be recorded and kept on file. Every concern of which the IACUC is made aware will receive attention and responses will be documented.

c All appropriate parties, including the Institutional Official and appropriate (e.g., Federal) oversight agencies, will be made aware, in writing, of the outcome(s).

d. Dependent upon the nature of the concern, the manner expressed and by whom, the IACUC or the Institutional Official will respond to those initiating the concern(s).

5. Make written recommendations to the Institutional Official regarding any aspect of the Institution’s animal program, facilities, or personnel training. The procedures for making recommendations to the Institutional Official are as follows: Any such recommendations will be made in writing to the Provost and records will be kept of all aspects thereof.

6. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are as follows:

a. Completed requests for approval of animal utilization are submitted to the IACUC by the Principal Investigator (PI) for each project at least 2 weeks prior to implementation.

b. Copies are provided to all IACUC members for discussion at the next scheduled monthly meeting, such discussion being lead by a ‘primary reviewer’. The primary reviewer is an IACUC member, assigned by the Chair, and not associated with the protocol. If any question arises prior to the IACUC meeting, additional details and/or a meeting with the PI may be requested.

c. A majority vote of the members constituting the quorum is required to approve a Committee action. Minority opinions are allowed to accompany any action.

d. Outcomes of the IACUC’s deliberation (i.e., approval, approval pending modifications to secure approval, action deferred, or action withheld) are communicated to investigators, in writing, with required modifications or reasons for the IACUC’s decision itemized.

e. Alternate members of the IACUC are appointed by the University President, receive training identical to full members, are specifically designated to which member they are an alternate. Alternate members may attend all meetings and replace (e.g., vote in place of) specifically designated members absent from a meeting. Alternates may also act as a member of the IACUC in authorizing clarifications of approved protocols, in authorizing amendments not requiring full committee action, in approving Exempt Protocols, and as members of Semiannual Program and Facility inspection teams.

f. The Designated Reviewer method may be used to review annual continuing reviews of protocols, significant amendments to protocols, and, in rare cases, new animal use protocols. Prior to Designated Member review, all IACUC members shall be given a copy of the proposed action and afforded an opportunity to comment and/or request full Committee review. If Full Committee is not requested, the IACUC chair assigns a qualified designated reviewer or subcommittee of reviewers from the Committee who review the protocol and either approves the protocol, requires modifications to secure approval, or refers the protocol to Full Committee review.

g. Complete approval (i.e., having no remaining conditions and/or restrictions resulting from a review) of the proposed activity MUST occur before any animal may be utilized.

7. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are identical to the procedures outlined in Item III.D.6 (above).

8. Notify investigators and the Institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy IV.C.4. The IA
CUC procedures to notify investigators and the Institution of its decisions regarding protocol review are as follows

a. Notification of investigators and the institution of IACUC decisions shall be the responsibility of the Office of the Provost, University of Mary Washington.

b. All such correspondence shall include any required modifications needed to secure approval or any reasons for protocol deferral or action withheld and giving investigators the opportunity to respond in person or in writing.

9. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing reviews are as follows:

a. Continuing reviews will be conducted at less then twelve (12) month intervals. Investigators will be notified by the Chair of the IACUC in writing prior to the expiration date and requested to submit a completed questionnaire and summary of the previous period’s activities.

b. Each IACUC member will be provided with a list of animal use protocols due for continuing review during the next 60 days as a component of the monthly full committee meeting information. Any member may request Full Committee review at any time.

c. With the exceptions noted below, continuing reviews will be conducted by two (2) committee members, one of which should be the Veterinarian and the other designated by the IACUC chair. Unless full Committee review is requested by either designated reviewer or a member of the IACUC, notification of review outcome is provided to the IACUC.

Continuing review of protocols involving the following procedures shall be reviewed by the full Committee (See Item III.D.6., above) in lieu of a designated review:

Such full Committee review may result in additional clarifications/information being requested from the investigator before a final recommendation can be given.

d. All correspondence regarding continuing reviews shall be handled by UMW as previously described (Item III.D.8.).

e. Each Animal-use protocol shall be unique and shall be active for a maximum period of three (3) years. At the end of this three-year period, it shall be automatically inactivated and all animal activities covered under it shall be considered complete. Ongoing or additional animal activities as may be required by the specific protocol must be submitted as a new animal use protocol, which will be assigned a new AUP number.

10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are

a. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC present. A majority vote is required and a minority opinion shall be allowed for opposing view point(s). If a suspension is authorized, all activity will immediately cease.

b. If circumstances involving animal health, safety, and/or welfare dictate, the Veterinarian, a subcommittee of the IACUC or the Institutional Official may temporarily suspend an activity. Such suspension and supporting evidence shall be reviewed by the full IACUC as in Item a. above.

c. All affected parties including, but not limited to, the investigator, the Institutional Official, and the appropriate oversight (e.g., Federal) agencies, shall be notified of the reasons for the suspension, any applicable corrective action(s) and any further action(s) anticipated.

E. The occupational health and safety program for personnel working in laboratory animal facilities or have frequent contact with animals is as follows:

All persons in contact with the animals shall undergo a training program which will include the following topics:

1. Basic laboratory safety

2. Basic care of laboratory animals, with an emphasis on the humane treatment of research animals.

3. Issues involving safety of both laboratory animals and investigators

4. Appropriate training in research methods to be used.

Successful completion of the programs will be documented, and this documentation maintained in the IACUC files.

F. The total gross number of square feet in each animal facility /area is given in item I (above) and in the Attachment (below) of these assurances.

The animals utilized and the average daily inventory of each for July 1, 2013 through June 30, 2014 are also given in Attachment (below) of these assurances:

G. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows: All personnel using animals must complete the training program offered by the IACUC.

Training and instruction of personnel must include guidance in several areas.

(1) Humane methods of animal maintenance and experimentation, including: [i] the basic needs of each species of animal; [ii] proper handling and care for the various species of animals used by the facility; [iii] proper pre- and post-procedural care of animals; and [iv] aseptic surgical methods and procedures.

(2) The concept, availability, and use of research or testing methods which limit the use of animals or minimize animal distress.

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animal used by the facility.

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of regulations or standards under the [Animal Welfare] Act.

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: [i] on appropriate methods of animal care and use; [ii] on alternatives to the use of live animals in research; [iii] unintended and unnecessary duplication of research involving animals; and [iv] the intent and requirements of the Act.

Additional instruction on the use of specific species, proper anesthetic/analgesic techniques, surgery, etc., is provided in small groups to personnel whose research involves the specific activities. Training may also be supplemented from on-line instructional programs from www.researchtraining.org.

In addition to the above, the institution provides opportunities for personnel involved directly in animal care to attend animal care related meetings. Members of the IACUC are encouraged and funded to attend various workshops on animal care and use provided by other institutions, organizations, and the OLAW.

IV. INSTITUTIONAL PROGRAM EVALUATION AND ACCREDITATION

All of this Institution’s programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC within the past six months and will be re-evaluated by the IACUC at least once every six months thereafter, in accord with the PHS Policy IV.B.1-2.

A. Reports will be prepared in accord with the PHS Policy IV.B.3.

B. All IACUC semiannual reports will include a description of the nature and extent of the Institution’s adherence to the “Guide.”

C. Any departures from the “Guide” will be identified specifically and reasons for each departure will be stated.

E. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency.

F. Semiannual reports of the IACUC’s evaluations will be submitted to the Institutional Official.

G Semiannual reports of IACUC evaluations will be maintained by this Institution and made available to the OLAW upon request.

V INSTITUTIONAL STATUS

This Institution is Category Two (2)—not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC). As noted above, reports of the IACUC’s semiannual evaluations (program reviews and facility inspections) will be made available upon request. The report of the most recent evaluations (program review and facility inspection) is attached.

VI. RECORDKEEPING REQUIREMENTS

A. This Institution will maintain for at least three years:

1. A copy of this Assurance and any modifications thereto, as approved by the PHS.

2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.

3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.

4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the Institutional Official, the Provost

5. Records of accrediting body determinations.

B. This Institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.

C. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

VII. REPORTING REQUIREMENTS

A. This Institution’s reporting period is January 1 through December 31. The IACUC, through the Institutional Official, will submit an annual report to OLAW on January 31 of each year. The report will include:

1. Any change in the accreditation status of the Institution (e.g,. if the Institution obtains accreditation by AAALAC or AAALAC accreditation is revoked), any change in the description of the Institution’s program for animal care and use as described in this Assurance, or any change in the IACUC membership. If there are no changes to report, this Institution will provide written notification that there are no changes.

2. Notification of the dates that the IACUC conducted its semiannual evaluations of the Institution’s program and facilities (including satellite facilities) and submitted the evaluations to the Institutional Official, Dr. John Morello, Associate Provost for Academic Affairs.

B. The IACUC, through the Institutional Official, will promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

1. Any serious or continuing noncompliance with the PHS Policy.

2. Any serious deviations from the provisions of the “Guide.”

3. Any suspension of an activity by the IACUC.

C. Reports filed under sections VI.A. and VI.B. of this document shall include any minority views filed by members of the IACUC.

*This information is mandatory.**Names of members, other than the chairperson and veterinarian, may be represented by a number or symbol in this submission to OLAW. Sufficient information to determine that all appointees are appropriately qualified must be provided and the identity of each member must be readily ascertainable by the Institution and available to authorized OLAW or other PHS representatives upon request.***PHS Policy Requirements – identify which IACUC members meet the four criteria below:

Veterinarian (V) – a veterinarian with direct or delegated program responsibility.

Nonscientist (NS) – a member whose primary concerns are in non-scientific areas (e.g. ethicist, lawyer, member of the clergy).

Nonaffiliated (NA) – a member who is not affiliated with the Institution in any way other than as a member of the IACUC, and who is not a member of the immediate family of a person who is affiliated. This member is expected to represent the interests of the general community in the proper care and use of animals and should not be a laboratory animal user. A consulting attending veterinarian may not be considered nonaffiliated.

Notes:

All members must be appointed by the CEO (or individual with specific written delegation to appoint members) and must be voting members. Ad hoc or nonvoting members may be listed and identified as such, but are not considered members for the purpose of the PHS Policy, and do not contribute to a quorum.

If Alternate members are listed, identify for whom (by name or code number, not specialty) they will serve as Alternates.

OTHER KEY CONTACTS (OPTIONAL)

If there are other individuals within the Institution who may be contacted regarding this Assurance, please provide information below.

Name:

Title:

Phone & Fax:

E-mail:

Name:

Title:

Phone & Fax:

E-mail:

FACILITY AND SPECIES INVENTORY

DATE: 6/11/2013

NAME OF INSTITUTION:

ASSURANCE NUMBER:

Laboratory, Unit, or Building*

Gross Square Feet (including service areas)

Species Housed in Unit (use complete common names)

Approx. Average Daily Inventory

Jepson Science Center Animal Room

200

Mouse/Rat (Sprague-Dawley)

25/10

Jepson Science Center Aquatic Research Laboratory

286.75

Danio rerio Zebra Fish

300

Annex A Rat Vivarium

110

Rat (Sprague-Dawley)

25

*Institutions may identify animal areas in any manner, e.g., initials, ID number, etc. However, the name and location must be provided to OLAW upon request.